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目的 :研制治疗妇科炎症的阴道缓释栓。方法 :研究该栓剂的制备方法 ,建立质量标准和稳定性试验。根据新药要求进行局部刺激试验。采用紫外分光光度法测定血浆中的替硝唑 ,在临床进行疗效观察。结果 :该栓剂质量稳定 ,无局部刺激性 ,药 -时曲线呈多峰 ,作用时间长达24h以上 ,临床治疗滴虫性阴道炎痊愈率为90 00 %。结论 :快净栓具优异的药动学特性 ,体内释药平稳 ,作用时间长 ,值得推广应用
OBJECTIVE: To develop a vaginal sustained release suppository for the treatment of gynecological inflammation. Methods: The suppository preparation method, the establishment of quality standards and stability tests. According to the requirements of new drugs for local stimulation test. Tinidazole in plasma was determined by UV spectrophotometry and the clinical efficacy was observed. Results: The suppository had stable quality and no local irritation. The drug - time curve was multimodal and the action time was longer than 24 hours. The cure rate of trichomonas vaginitis was 90 00%. Conclusion: Fast-acting suppository with excellent pharmacokinetic properties, stable release in vivo, long duration of action, and worthy of promotion and application